tafluprost and Ocular-Hypotension

Prostaglandin analogs (PGAs) are the first-line treatment for primary open-angle glaucoma (POAG) and ocular hypertension (OH). This study aimed to confirm the effectiveness and safety of Tapros® (0.0015% tafluprost eye drops) in Chinese patients with POAG and OH.. This phase IV, multicenter, non-comparative, prospective study enrolled patients with POAG and OH in China between 12/27/2017 and 04/15/2020. Patients who were treatment-naïve or untreated within one month (group A) or with unreached intraocular pressure (IOP) target after previous monotherapy of other PGAs (group B) or non-PGA IOP-lowering drugs (group C) were treated with 0.0015% tafluprost for three months. The IOP reduction, response rate, and safety were observed.. There were 165, 89, and 31 patients in groups A, B, and C, with baseline IOPs of 22.4 ± 4.7, 21.0 ± 3.5, and 22.5 ± 3.2 mmHg, respectively. The least-square means and percentages of IOP reduction at 3 months for groups A, B, and C were 4.7 (19.8%), 1.6 (6.1%), and 4.6 mmHg (20.3%), respectively. A significant reduction in IOP was observed at each visit compared with baseline (all P < 0.05). At the final visit, 57.0% of the participants in group A achieved an IOP reduction of ≥ 20%, while 40.4% and 77.4% in groups B and C achieved an IOP reduction of ≥ 10%. Fifty-eight treatment-related adverse events occurred in 46 participants (15.7%), of which the most common one was conjunctival hyperemia (34/293, 11.6%).. Tafluprost showed a sustained and significant effect with tolerable adverse events in Chinese patients with POAG and OH who were treatment-naïve or untreated within one month or received prior treatments with unsatisfying outcomes.

Topics: Antihypertensive Agents; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Marketing; Ocular Hypertension; Ocular Hypotension; Prospective Studies; Prostaglandins F; Prostaglandins, Synthetic; Treatment Outcome

To determine the proportion of latanoprost low-responders among cynomolgus monkeys, and to evaluate the switching efficacy from latanoprost to tafluprost in latanoprost low-responder monkeys.. Thirty-nine ocular normotensive monkeys were used in this study. Latanoprost low-responders were detected using a 2-step evaluation procedure. In the first step, the response to single administration of latanoprost was investigated in all monkeys. In the second step, the response to 7-day administration of latanoprost was evaluated in screened monkeys. We defined latanoprost low-responders as any monkey that showed intraocular pressure (IOP) reduction of 1 mm Hg or less during the 7-day treatment. Switching efficacy from latanoprost to tafluprost was then evaluated in a 3-phase switching study. Latanoprost was topically administered for about 1 week in phases 1 and 3, with tafluprost being topically administered for about 1 week in phase 2.. Eleven monkeys were "latanoprost low-responders." The maximal IOP reduction exhibited by these low-responders in the second step of the evaluation was 0.5±0.2 mm Hg (mean±SEM) during saline treatment and 0.8±0.2 mm Hg during latanoprost treatment. In the 3-phase switching study, the maximal IOP reductions were: 0.4±0.2 mm Hg in phase 1 (latanoprost), 2.4±0.3 mm Hg in phase 2 (tafluprost), and 0.5±0.2 mm Hg in phase 3 (latanoprost).. Latanoprost low-responders exist among cynomolgus monkeys. Switching from latanoprost to tafluprost reduced IOP, and tafluprost's IOP-lowering effect disappeared after switching back to latanoprost in the latanoprost low-responder monkeys. These results suggested that tafluprost might be effective for latanoprost nonresponder patients.

Topics: Administration, Topical; Animals; Antihypertensive Agents; Drug Substitution; Intraocular Pressure; Latanoprost; Macaca fascicularis; Male; Ocular Hypotension; Prostaglandins F; Prostaglandins F, Synthetic; Tonometry, Ocular